Advertisement Parion begins Phase II trial of P-1037 to treat cystic fibrosis - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Parion begins Phase II trial of P-1037 to treat cystic fibrosis

Parion Sciences, a company dedicated to the development of novel treatments for pulmonary and ocular diseases, has begun enrollment of a phase 2 clinical trial of P-1037 in patients with Cystic Fibrosis (CF).

The trial has been named the "CLEAN-CF" trial which refers to "Clearing Lungs with ENaC inhibition in Cystic Fibrosis". The CLEAN-CF study will include CF patients regardless of an individual’s genetic mutation. Inhibiting the epithelial sodium channels (ENaC) in the airways with P-1037, an "ENaC blocker," is expected to re-hydrate the mucus layers, thus restoring airway clearance, improve lung function and, ultimately, reduce exacerbations.

P-1037 has demonstrated to be long acting in preclinical models and to have a favorable safety and tolerability profile in the completed Phase 1 studies. The initiation of the Phase 2 clinical trials was supported by an award from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the nonprofit affiliate of the Cystic Fibrosis Foundation.

Parion expects to enroll approximately 120 patients at 30 sites, most within CFFT’s clinical trials national network.

"With P-1037 we look forward to the potential of having a novel therapy that is effective for people with cystic fibrosis regardless of their specific genotype," said Dr. Scott Donaldson, Associate Professor of Medicine at the University of North Carolina, Chapel Hill and Co-Primary Investigator for the CLEAN-CF Trial.

CF is a rare genetic disease affecting approximately 30,000 individuals in the US and 70,000 world-wide. CF is caused by a gene mutation and its protein product, called CFTR, and the inability of the epithelial cells of the lung to provide sufficient fluid to the mucus layer.

Mucus hydration is maintained by the balance of airway ion transport that regulates fluid secretion (hydrating) and fluid absorption (dehydrating).

"Initiating this phase 2 study in CF represents a major milestone for Parion as we continue on our mission to advance our first-in-class therapy to treat all CF patients," said Paul Boucher, President of Parion.

"The Parion team, our partners and the participating clinical sites, combined with Cystic Fibrosis Foundation Therapeutics’ support, have worked expeditiously to achieve this milestone as we now focus towards enrolling patients."